Recall Z-1389-04 ยท HBT Applier, Hemostatic Clip
Weck
Ref. No. 523771 - Hemoclip, 15 Large Titanium Clips/Cartridge (Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large Titanium Clips/Cartridge (Non-Steile)
| Date | Aug 24, 2004 (initiated Oct 24, 2003) |
| Status | Terminated |
| Reason | Hole in the sterile unit blister pack that could compromise sterility. |
| Root cause | Other |
| Action | The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product. |
| Quantity | 91,869 units for all products under recall |
| Distribution | Nationwide and to accounts in Canada, Europe Asia, and South/Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.